Informational MDSAP Substantial change / Change of notice forms

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world217

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#1
#1
Hello,

First of all, I am sorry, as I was not sure if this is the correct thread where I should address this.

We are currently preparing for MDSAP and right now I am working on having the Substantial change and change of notice forms for each country as per the requirements. However, they seem to be called differently in each country and I am a bit lost (eg. TGA: conformity assessment certification = notification of change?).

For substantial change we plan to do was single file (a section for each country) and for notification of change a document for each one.

Could anyone help clarifying the name and corespondent for each? Once this is clear to me I can start working on creating/ updating the template accordingly.

Any piece of information would be very useful. Thank you!
 
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Ronen E

Ronen E

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#2
#2
In Australia "Conformity Assessment" means a verification that the manufacturer and device(s) are in compliance (conformity) with the applicable regulations.
"Conformity Assessment Procedure" means a route, prescribed in the regulations, that is followed for performing the Conformity Assessment (similar to the EU MDD Annexes).
"Conformity Assessment Certification" is the auditing process that normally leads to issuing a certificate attesting that a correct Conformity Assessment Procedure has been completed successfully (similar to an EC certificate).

It is not a notification of change.
 
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world217

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#3
#3
Thank you very much for clarifying, this is very useful. I could see that they have notification of substantial change (https://www.tga.gov.au/book-page/4-notification-substantial-changes-and-transfers), but what do they use for the notification of change? I am actually struggling in general to understand the process of submitting substantial changes and notification of changes to the regulatory authorities (not just for Australia) because I never really handled it in my area of work (I started in QA working strictly just on post market surveillance, then one year into it switched to taking care of an entire QMS, so the amount of information is sometimes a bit overwhelming).
 
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